Overview
Reporting to the Head of Quality UK, the Quality Assurance Regulatory Manager can be located at a choice of Company UK locations, with the opportunity for some remote working.
Responsibilities
- Providing Regulatory Leadership with accountability for Regulatory Compliance Across seven UK Licensed Sites, ensuring consistent application of GMP, GDP and MHRA requirements
- Key interface between Quality Assurance, Regulatory Affairs, Operations and external regulatory bodies, ensuring consistent standards, robust systems and inspection readiness across the network
- Experience in commercial and Investigational Medicinal Product (IMP) development, including early‑phase and clinical trial supply within a sterile manufacturing environment
- Combining strategic oversight with hands‑on regulatory input, supporting routine commercial operations and development programmes
- Deputise for Head of Quality for UK regulatory issues
- Participate in site client audits and inspections by regulatory authorities
- QA regulatory lead for commercial and IMP activities
- Support regulatory interactions with MHRA and other authorities, including inspections, audits, responses and ongoing compliance commitments
- Ensure site licences, variations and regulatory submissions are maintained and aligned with operational and development activities
- Review and approve quality and regulatory documentation, including SOPs, batch documentation, validation protocols and development reports
Qualifications
- Degree or higher in quality, or regulatory, or equivalent experience in a pharmaceutical setting
- Strong background in regulatory with a minimum of 5 years’ experience
- Previous managerial or supervisory experience with a demonstrable track record of strong performance
- Experience of pharmacovigilance, is desirable
- Proven regulatory experience within nuclear medicine, sterile manufacturing or aseptic processing environments
- Demonstrable experience of supporting commercial and IMP product development, including clinical trial supply and IMPD preparation/review
- Strong working knowledge of UK and EU GMP, MHRA regulatory requirements and GxP compliance
- Experience working across multi-site operations, with the ability to implement consistent quality standards at scale
- Background in regulatory inspections, audits and authority interactions within a licensed manufacturing environment
- Experience collaborating cross-functionally with manufacturing, quality control, development and clinical teams
- Confident communicator (spoken and written), with ability to operate at operational and senior stakeholder level
- Experience with Microsoft Windows, Word, Excel and PowerPoint
QA Regulatory Manager employer: ARx Recruitment Services
As a Quality Control Technician, you will join a dynamic team dedicated to maintaining the highest standards of quality in our products. Our company fosters a collaborative work culture that values employee input and offers ample opportunities for professional growth and development. Located in a vibrant area, we provide competitive benefits and a supportive environment that makes us an excellent employer for those seeking meaningful and rewarding careers.
